ENDOTAK RELIANCE SG Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1993 · 4 device variants grouped
Total Reports
5,915
Reports (30d)
45
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Gradual Rise in Shock Impedance Measurements
technical services, shock impedance, ohms, range, impedance measurements
52
reports
High Shock Impedance with Technical Services Involved
reprogramming, remains service, technical services, shock impedance, impedance measurements
13
reports
High Shock Impedance in CRT-D System
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator
11
reports
High Shock Impedance with Reprogramming Suggested
implantable cardioverter, icd, shock, technical services, defibrillator icd
11
reports
Lead Revision Due to Infection
explanted right, infection additional, effects, revision infection, lead revision
10
reports
Lead Replacement Due to Performance Anomaly
effects, dislodgement, reported right, additional adverse, new lead
8
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
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